Per-Q-Cath Plus CatheterRecalls & reported problems across all models

We found 13 models of Per-Q-Cath Plus Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 622 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2015 and Aug 29, 2024 — classified as 24 injuries, 598 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (288 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Per-Q-Cath Plus Catheter problems

Per-Q-Cath Plus Catheter models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Per-Q-Cath Plus Catheter 4132105

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  262 reports
• Per-Q-Cath Plus Catheter 4133105

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  140 reports
• Per-Q-Cath Plus Catheter 4134115

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  94 reports
• Per-Q-Cath Plus Catheter 4132005

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  34 reports
• Per-Q-Cath Plus Catheter 4132100

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  30 reports
• Per-Q-Cath Plus Catheter 4134105

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  20 reports
• Per-Q-Cath Plus Catheter 4135105

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  12 reports
• Per-Q-Cath Plus Catheter 4135115

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  11 reports
• Per-Q-Cath Plus Catheter 4235105

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  7 reports
• Per-Q-Cath Plus Catheter 4132000

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  4 reports
• Per-Q-Cath Plus Catheter 4133115

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  3 reports
• Per-Q-Cath Plus Catheter 4234105

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  3 reports
• Per-Q-Cath Plus Catheter 4133110

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  2 reports

Recent Per-Q-Cath Plus Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED CATHETER BROKE WHEN HANDLED BEFORE INSERTION INTO PATIENT. THERE WAS NO HARM TO THE PATIENT, THE MATERIAL SHOWED A QUALITY DEVIATION BEFORE BEING IMPLANTED IN THE PATIENT. PARTIAL BREAK. NO DELAY IN TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20093162 ↗
• MalfunctionJul 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, PICC PASSAGE ATTEMPTED, BUT THE INDUCTOR IS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824686 ↗
• MalfunctionNov 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN WATERPROOFING THE CATHETER, IT IS NOTED THAT IT HAS A HOLE. NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103583 ↗
• InjurySep 20, 2023Break; Break

  IT WAS REPORTED THE CATHETER RUPTURED WHEN INSERTED INTO THE PATIENT AND WAS COMPLETELY REMOVED WITH THE AID OF FORCEPS, WITHOUT CAUSING HARM TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17785346 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WHEN PERFORMING THE INSERTION AND PREPARATION OF THE PICC INSERTION TECHNIQUE, THE TEST WAS CARRIED OUT AND IT WAS OBSERVED THAT IT WAS PERFORATED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708913 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CATHETER WAS OPENED FOR PRE-FLUSHING, IT WAS FOUND THAT THE CATHETER WAS BROKEN AND LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638748 ↗
• MalfunctionAug 22, 2023Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A PICC CATHETER WAS PLACED AND DURING THE GUIDEWIRE REMOVAL IT UNRAVELED DURING TRACTION. IT WAS NEEDED TO RESTART THE PROCEDURE WITH A NEW CATHETER AND NEW INSERTION MATERIALS. ADDITIONAL INFORMATION RECEIVED 10 AUGUST 2023: THE PROCEDURE LASTED FOR ANOTHER 30 MINUTES, BEYOND THE SCHEDULED TIME. THE PATIENT COMPLAINED OF PAIN WHILE THE GUIDEWIRE WAS BEING REMOVED, IMAGING TESTS WERE PERFORMED, AND THE CURRENT PATIENT IS CLINICALLY STABLE, WITH IMPROVEMENT IN BREATHING PATTERNS. THERE WAS NO NEED TO ADMINISTER PAIN MEDICATION, AS THE PAIN RESOLVED AFTER REMOVAL OF THE GUIDE WIRE. A CHEST X-RAY WAS PERFORMED AFTER THE PROCEDURE TO ANALYZE WHETHER THERE WAS ANY DAMAGE CAUSED BY THE EVENT. THE PATIENT WOULD EXCHANGE THE CENTRAL VENOUS CATHETER FOR THE PICC DUE TO THE INDICATION TIME FOR PERMANENCE OF THE CENTRAL VENOUS CATHETER THAT HAD EXPIRED. THE PICC WOULD BE USED FOR THE INFUSION OF VENOUS SOLUTIONS NECESSARY FOR THE MAINTENANCE OF HIS LIFE. THERE IS NO OTHER RELEVANT HISTORY OR CONCOMITANT THERAPY.

  Patient problems: Pain

  MAUDE report 17597546 ↗
• MalfunctionJul 26, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER, "INSIDE THE PACKAGING OF THE CATHETER IS A STRAND OF HAIR". ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER 7/21/2023: "THE PRODUCT IS NOT DAMAGED, THE PACKAGING IS NOT TORN, THE HAIR IS INSIDE THE PACKAGING, WHICH IS SEALED. YOU CAN SEE IT THROUGH THE PLASTIC".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17399040 ↗
• MalfunctionJun 7, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER TECHNICAL AREA, "PICC RUPTURED SPONTANEOUSLY AFTER 8 DAYS OF USE IN THE NB, WHILE INFUSING INTRAVENOUS HYDRATION. IT RUPTURED ON THE OUTSIDE, WAS REMOVED IMMEDIATELY, NEONATOLOGIST INFORMED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083603 ↗
• MalfunctionMay 17, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON OPENING OF THE MIDLINE¿S PACKAGE, THE PROXIMAL END OF THE GUIDE WIRE INSIDE WAS FOUND BENT. IT WAS NOT SURE IF THE CATHETER WAS DAMAGED OR NOT. THE PRODUCT WAS THEREFORE UNUSABLE. (B)(6) 2023 - THE CUSTOMER REPORTED A BENT GUIDEWIRE HOWEVER A STYLET WAS RETURNED FOR EVALUATION AND EXHIBITED MULTIPLE BENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950903 ↗
• MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE MATERIAL PRESENTED AN ISSUE DURING ITS PLACEMENT. ACCORDING TO THE REPORTER, TO INSERT THE CATHETER INTO PATIENT IT WAS PERFORMED THE MANDREL REMOVAL AND TESTED WITH SALINE SOLUTION, WHEN THE SOLUTION WAS INFUSED A LEAKAGE WAS NOTED IN THE CATHETER. WHEN THE DEVICE WAS INSPECTED, A CRACK WAS OBSERVED. IT WAS NEEDED ANOTHER CATHETER TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773073 ↗
• MalfunctionApr 13, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER PERFORATION DURING GUIDEWIRE REMOVAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740521 ↗
• MalfunctionMar 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CENTRAL VENOUS ACCESS CATHETER CAME WITH HOLES SO IT WAS NOT USED IN A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475440 ↗
• MalfunctionFeb 3, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CLINICIAN THAT "THE PRODUCT BROKE IN THE BUTTERFLY DURING HANDLING TO CARRY OUT THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294774 ↗
• MalfunctionJan 24, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "REQUESTED A PICC PLACEMENT IN PEDIATRIC ICU PATIENT. HOWEVER, WHEN PASSING THE PICC AND REMOVING THE GUIDEWIRE, IT DIDN'T COME OUT. 3 MORE PUNCTURE ATTEMPTS WERE TRIED AGAIN, AND THE ISSUE HAPPENED AGAIN. A NEW CATHETER WAS USED. " ON 11/23/2022: ADDITIONAL INFORMATION: IT WAS REPORTED, THERE WAS AN EXPOSURE IN A PROCEDURE THAT WAS NOT SUCCESSFUL DUE TO THE MATERIAL USED. DISSATISFACTION OF THE DOCTOR AND FAMILY MEMBERS AND FRUSTRATION FOR THE PROCEDURE DID NOT WORK. ON 11/28/2022: ADDITIONAL INFORMATION: IT WAS REPORTED, THE PATIENT¿S HOSPITAL STAY WAS NOT PROLONGED DUE TO THE UNSUCCESSFUL PICC PLACEMENT, BUT IT COULD HAVE OPTIMIZED THE TIME IF THE FIRST PASS WAS SUCCESSFUL. ON 1/6/2023 : FOUND DURING EVALUATION, THE RETURNED STYLET EXHIBITED MULTIPLE KINKS AND BENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237482 ↗

Other Bard Access Systems, Inc. products

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• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports